NCT06587139

Brief Summary

The purpose of this project is to develop and evaluate an online mentoring and skill-building program for transgender and/or gender minority youth (TGMY) ages 14 to 18, the Teen Connection Project (TCP). The TCP includes seven 90-minute sessions facilitated by transgender and/or gender minority (TGM) adults (who are also mentors). TGMY will be paired with a TGM adult mentor, based on their shared interests. Mentors and mentees will participate together in each session along with other mentors and mentees. Mentors will direct activities and discussion to promote TGMY social-emotional skills. The TCP sessions will include one-on-one mentor-mentee break-out sessions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 22, 2024

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 9, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 3, 2025

Completed
Last Updated

November 5, 2025

Status Verified

November 1, 2025

Enrollment Period

11 months

First QC Date

August 9, 2024

Last Update Submit

November 3, 2025

Conditions

Keywords

Risk-TakingSexual BehaviorSex OffensesIntimate Partner ViolenceCrime Victims

Outcome Measures

Primary Outcomes (10)

  • Alcohol Use (Youth-reported)

    Youth Risk Behavior Survey Questionnaire (YRBSS). Minimum Value = 0, Maximum Value = 6, Higher scores = worse outcomes

    Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

  • Drug Use (Youth-reported)

    YRBSS. Minimum Value = 0, Maximum Value = 5, Higher scores = worse outcomes

    Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

  • Sexual Risk-Taking (Youth-reported)

    Researcher-created items, adapted items with input from a youth advisory board from, YRBSS, and Sexual Risk Taking Survey. Minimum Value = 1, Maximum Value = 7, Higher scores = worse outcomes

    Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

  • Dating and Sexual Violence (DSV) victimization-1 (Youth-reported)

    Measure of Adolescent Relationship Harassment and Abuse (MARSHA). Minimum Value = 0, Maximum Value = 3, Higher scores = worse outcomes

    Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

  • DSV perpetration-1 (Youth-reported)

    MARSHA. Minimum Value = 0, Maximum Value = 3, Higher scores = worse outcomes

    Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

  • DSV victimization-2 (Youth-reported)

    CTS-2: SGM-Specific Intimate partner Violence (IPV) Tactics Scale \[CTS = Conflict Tactics Scale, SGM = sexual and gender minority\]. Minimum Value = 0, Maximum value = 3, Higher scores = worse outcomes

    Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

  • DSV perpetration-2 (Youth-reported)

    CTS-2: SGM-Specific IPV Tactics Scale. Minimum Value = 0, Maximum Value = 3, Higher scores = Worse outcomes

    Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

  • Depressive symptoms (Youth-reported)

    Patient Health Questionnaire for Adolescents (PHQ-9). Minimum Value = 0, Maximum Value = 3, Higher scores = Worse outcomes

    Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

  • Anxiety symptoms (Youth-reported)

    Generalized Anxiety Disorder Screener (GAD-7). Minimum Value = 0, Maximum Value = 3, Higher scores = Worse outcomes

    Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

  • Suicidality (Youth-reported)

    Suicidal Ideation Attributes Scale (SIDAS). Minimum Value = 0, Maximum Value = 10, Higher scores = Better outcomes

    Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

Other Outcomes (7)

  • Social-Emotional Competence (Youth-reported)

    Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

  • Gender Minority Stress (Youth-reported)

    Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

  • Outness (Youth-reported)

    Time 1 (baseline, pre-intervention), Time 2 (immediately post-intervention), Time 3 (3 months post-intervention)

  • +4 more other outcomes

Study Arms (3)

Treatment

EXPERIMENTAL

The Teen Connection Project (TCP) is theoretically grounded, and follows best practices for effective health behavior prevention. It includes seven 90-minute sessions with group and one-on-one mentoring components. The intervention is facilitated by transgender and/or gender minority adults (i.e., any identity other than cisgender).

Behavioral: Teen Connection Project (TCP)

Waitlist control

NO INTERVENTION

Provide check-ins, provide resources, and offer program after intervention and measurement has been completed.

Mentors

NO INTERVENTION

Mentors complete a two-day training and post-training survey, facilitate programming, and complete post-session surveys. A subset of the mentors will complete exit interviews.

Interventions

The Teen Connection Project (TCP) includes seven 90-minute sessions facilitated by transgender and/or gender minority (TGM) adults. Each transgender and/or gender minority youth (TGMY) will be paired with a TGM adult mentor based on TGMYs' rank-ordered preference for mentors. The research team seeks to match mentors \& mentees such that each TGMY is matched with one of their top 3 preferred mentors. Mentors and mentees participate together in each session along with other mentors \& mentees. Facilitators direct activities/discussion to promote TGMY social-emotional skills acquisition and facilitate mentor-mentee conversations. TCP sessions also include mentor-mentee breakout sessions where mentors share challenges they personally faced as TGMY and how they overcame them. Break-out discussions focus on self-acceptance, coming out, dating questions, hopes and goals for the future, \& how other marginalized social identities, such as race and ethnicity, intersect with identifying as TGMY.

Also known as: TCP
Treatment

Eligibility Criteria

Age14 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsTransgender and/or gender minority (i.e., any identity other than cisgender)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • identify as transgender and/or gender minority youth (TGMY) (i.e., any identity other than cisgender)
  • be between the ages of 14 to 18 years
  • read and speak English
  • live in the United States
  • report consistent access to a phone, tablet, and/or computer with high-speed internet access/Wi-Fi (which represents 90+% of youth in the United States)
  • report an ability to attend seven, 90-minute online sessions at pre-determined times
  • pass an assent quiz
  • report moderate to high levels of internalized transphobia

You may not qualify if:

  • be at imminent risk for suicide (e.g., intent to kill themselves in the immediate future) as determined by an initial online suicide screening regarding their past month suicide risk (the Suicide Behaviors Questionnaire-Revised \[SBQ-R\]; modified to assess past month risk)
  • demonstrate current psychosis as determined by the Prodromal Questionnaire; modified to just focus on visual and auditory symptoms
  • be 30 years old or older
  • identify as transgender and/or gender minority (i.e., any identity other than cisgender)
  • not be currently experiencing substance use disorder or mental health challenges

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

[online program, administered by the University of Nebraska-Lincoln]

Lincoln, Nebraska, 68508, United States

Location

Related Publications (16)

  • CDC (2023). Youth Risk Behavior Survey. Centers for Disease Control and Prevention. https://www.cdc.gov/healthyyouth/data/yrbs/index.htm

    BACKGROUND
  • Turchik JA, Garske JP. Measurement of sexual risk taking among college students. Arch Sex Behav. 2009 Dec;38(6):936-48. doi: 10.1007/s10508-008-9388-z. Epub 2008 Jun 19.

    PMID: 18563548BACKGROUND
  • Rothman EF, Cuevas CA, Mumford EA, Bahrami E, Taylor BG. The Psychometric Properties of the Measure of Adolescent Relationship Harassment and Abuse (MARSHA) With a Nationally Representative Sample of U.S. Youth. J Interpers Violence. 2022 Jun;37(11-12):NP9712-NP9737. doi: 10.1177/0886260520985480. Epub 2021 Jan 5.

    PMID: 33399026BACKGROUND
  • Rothman EF, Paruk J, Cuevas CA, Temple JR, Gonzales K. The Development of the Measure of Adolescent Relationship Harassment and Abuse (MARSHA): Input From Black and Multiracial, Latinx, Native American, and LGBTQ+ Youth. J Interpers Violence. 2022 Mar;37(5-6):2126-2149. doi: 10.1177/0886260520936367. Epub 2020 Jul 5.

    PMID: 32627640BACKGROUND
  • Dyar C, Messinger AM, Newcomb ME, Byck GR, Dunlap P, Whitton SW. Development and Initial Validation of Three Culturally Sensitive Measures of Intimate Partner Violence for Sexual and Gender Minority Populations. J Interpers Violence. 2021 Aug;36(15-16):NP8824-NP8851. doi: 10.1177/0886260519846856. Epub 2019 May 5.

    PMID: 31057032BACKGROUND
  • Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.

    PMID: 16717171BACKGROUND
  • Richardson LP, McCauley E, Grossman DC, McCarty CA, Richards J, Russo JE, Rockhill C, Katon W. Evaluation of the Patient Health Questionnaire-9 Item for detecting major depression among adolescents. Pediatrics. 2010 Dec;126(6):1117-23. doi: 10.1542/peds.2010-0852. Epub 2010 Nov 1.

    PMID: 21041282BACKGROUND
  • van Spijker BA, Batterham PJ, Calear AL, Farrer L, Christensen H, Reynolds J, Kerkhof AJ. The suicidal ideation attributes scale (SIDAS): Community-based validation study of a new scale for the measurement of suicidal ideation. Suicide Life Threat Behav. 2014 Aug;44(4):408-19. doi: 10.1111/sltb.12084. Epub 2014 Feb 24.

    PMID: 24612048BACKGROUND
  • Zhou M, Ee J. Development and validation of the Social Emotional Competence Questionnaire (SECQ). The International Journal of Emotional Education. 2012;4(2):27-42.

    BACKGROUND
  • Hidalgo MA, Petras H, Chen D, Chodzen G. The Gender Minority Stress and Resilience Measure: Psychometric Validity of an Adolescent Extension. Clin Pract Pediatr Psychol. 2019;7(3):278-290. doi: 10.1037/cpp0000297.

    PMID: 33224698BACKGROUND
  • Meidlinger, P. C., & Hope, D. A. (2014). Differentiating disclosure and concealment in measurement of outness for sexual minorities: The Nebraska Outness Scale. Psychology of Sexual Orientation and Gender Diversity, 1(4), 489.

    BACKGROUND
  • Riggle, E. D., Mohr, J. J., Rostosky, S. S., Fingerhut, A. W., & Balsam, K. F. (2014). A multifactor lesbian, gay, and bisexual positive identity measure (LGB-PIM). Psychology of Sexual Orientation and Gender Diversity, 1(4), 398.

    BACKGROUND
  • University of Connecticut and the Human Rights Campaign. 2022 National Survey on LGBTQ Youth Mental Health. https://www.thetrevorproject.org/survey-2022/

    BACKGROUND
  • Turchik JA, Garske JP. Sexual risk survey. In: Fisher TD, Davis CM, Yarber WL, Davis SL, eds. Handbook of sexuality-related measures. 3rd ed. Routledge; 2010:600-602.

    BACKGROUND
  • Tolan PH, McDaniel HL, Richardson M, Arkin N, Augenstern J, DuBois DL. Improving understanding of how mentoring works: Measuring multiple intervention processes. J Community Psychol. 2020 Aug;48(6):2086-2107. doi: 10.1002/jcop.22408. Epub 2020 Jul 11.

    PMID: 32652575BACKGROUND
  • Keller TE, Drew AL, Herrera C, Clark-Shim H, Spencer R. Do program practices matter for mentors?: How implementation of empirically supported program practices is associated with youth mentoring relationship quality. J Community Psychol. 2023 Nov;51(8):3194-3215. doi: 10.1002/jcop.23019. Epub 2023 Feb 25.

    PMID: 36840743BACKGROUND

MeSH Terms

Conditions

Recreational Drug UseDepressionAnxiety DisordersSuicidal IdeationRisk-TakingAlcohol DrinkingSexual Behavior

Condition Hierarchy (Ancestors)

BehaviorBehavioral SymptomsMental DisordersSuicideSelf-Injurious BehaviorDrinking Behavior

Study Officials

  • Katie M Edwards, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: transgender and/or gender minority youth (TGMY) (n=80) are randomly assigned to a treatment (n=40) or wait-list (n=40) control condition.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, School of Social Work Director, Interpersonal Violence Research Laboratory (IVRL)

Study Record Dates

First Submitted

August 9, 2024

First Posted

September 19, 2024

Study Start

July 22, 2024

Primary Completion

June 3, 2025

Study Completion

June 3, 2025

Last Updated

November 5, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

This data will not be shared publicly. However, the PI intends to share the aggregated, de-identified quantitative survey data if users commit to the following: (a) using the data only for research purposes and not to identify any individual participant; (b) securing the data using appropriate computer technology; and (c) destroying or returning the data after analyses are completed. If the researcher agrees, in writing, to these stipulations, the PI will send them (via a link to a secure UNL OneDrive folder) the dataset prepared using SPSS (latest version available).

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Data will become available in December of 2025. It will be available for 7 years until December of 2032.
Access Criteria
The PI intends to share the aggregated, de-identified quantitative survey data if users commit to the following: (a) using the data only for research purposes and not to identify any individual participant; (b) securing the data using appropriate computer technology; and (c) destroying or returning the data after analyses are completed. If the researcher agrees, in writing, to these stipulations, the PI will send him/her the dataset prepared using SPSS 24.0 (or the latest version available). The prepared data set will not include identifying information from any participant. The master list will be destroyed as soon as participants' data are linked across time. Research participants will be identified by number. A detailed codebook will be prepared and supplied with the data indicating information about each variable as well as how composite scale scores are calculated. The syntax for any data imputations will also be provided.

Locations